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NCT03681327 Clinical Trial

Sleep Infra-slow Oscillations III

Healthy Clinical Trial

— Sleep-ISO III  

Official title:
Sleep Infra-slow Oscillations III: an Observational Study in Healthy Subjects and Patients With Sleep Disorders With and Without Closed-loop Stimulation During Sleep

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03681327
Other study ID # EOC.NSI.LS.18.1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date July 1, 2023

Study information
Verified date November 2023
Source Neurocenter of Southern Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Willingness to participate and written informed consent - Aged 20 to 40 years at the time of screening - Body mass index (BMI) = 30 Exclusion Criteria: - Pregnancy or breast feeding at the time of screening - Sleep related breathing disorders - Any other sleep related breathing disorder according to AASM criteria - Current history of psychiatric disorders according to DSM-V - Current chronic treatment that may affect sleep - Any significant neurological disorder or other medical disease that may affect sleep - Any unstable medical condition - Any clinically significant sleep disorder

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sensory stimulation during sleep
Sensory stimulation during sleep

Locations
Country Name City State
Switzerland Neurocenter of Southern Switzerland Lugano Ticino

Sponsors (1)
Lead Sponsor Collaborator
Neurocenter of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Arousal probability Number stimuli that are followed by an EEG arousal divided by the total number of stimuli 8 hours
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